Clarification of Reporting Requirements, 44160-44161 [2015-18113]
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44160
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
environmental assessment. The
exemption from the requirement to have
an STA in place is eligible for
categorical exclusion under 10 CFR
51.22(c)(25)(vi)(H), which provides that
exemptions from surety, insurance, or
indemnification requirements are
categorically excluded if the exemption
would not result in any significant
hazards consideration; change or
increase in the amount of any offsite
effluents; increase in individual or
cumulative public or occupational
radiation exposure; construction
impacts; or increase in the potential for
or consequence from radiological
accidents. The NRC staff finds that the
STA exemption involves surety,
insurance and/or indemnity
requirements and that granting Lost
Creek this temporary exemption from
the requirement of establishing a
standby trust arrangement would not
result in any significant hazards or
increases in offsite effluents, radiation
exposure, construction impacts, or
potential radiological accidents.
Therefore, an environmental assessment
is not required.
IV. Conclusions
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Accordingly, the NRC has determined
that, pursuant to 10 CFR 40.14(a), the
proposed temporary exemption is
authorized by law, will not present an
undue risk to the public health and
safety, is consistent with the common
defense and security, and is in the
public interest. NRC hereby grants Lost
Creek ISR, LLC an exemption from the
requirement in 10 CFR part 40,
Appendix A, Criterion 9 to set up a
standby trust to receive funds in the
event the NRC or the State regulatory
agency exercises is right to collect the
surety. This exemption will expire on
February 10, 2015, for the Lost Creek
ISR Project. At that time, Lost Creek will
be required to ensure compliance with
the STA requirements.
Dated at Rockville, Maryland, this 16th day
of July 2015.
For the Nuclear Regulatory Commission.
Andrew Persinko,
Deputy Director, Division of
Decommissioning, Uranium Recovery and
Environmental Programs, Office of Nuclear
Material Safety and Safeguards.
[FR Doc. 2015–18236 Filed 7–23–15; 8:45 am]
BILLING CODE 7590–01–P
[NRC–2015–0172]
Clarification of Reporting
Requirements
Nuclear Regulatory
Commission.
ACTION: Draft regulatory issue summary;
request for comment.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is seeking public
comment on a draft regulatory issue
summary (RIS). This draft RIS clarifies
reporting requirements related to
analyses of emergency core cooling
system performance and how these
reporting requirements apply to
applicants for and holders of nuclear
power reactor operating licenses,
construction permits, combined
licenses, standard design approvals, and
manufacturing licenses, and applicants
for standard design certifications.
DATES: Submit comments by September
22, 2015. Comments received after this
date will be considered if it is practical
to do so, but the Commission is able to
ensure consideration only for comments
received before this date.
ADDRESSES: You may submit comments
by any of the following methods (unless
this document describes a different
method for submitting comments on a
specific subject):
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2015–0172. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Mail comments to: Cindy Bladey,
Office of Administration, Mail Stop:
OWFN–12–H08, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001.
For additional direction on obtaining
information and submitting comments,
see ‘‘Obtaining Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Alexandra Popova, Office of Nuclear
Reactor Regulation, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–001; telephone: 301–415–
2876, email: Alexandra.Popova@
nrc.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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I. Obtaining Information and
Submitting Comments
NUCLEAR REGULATORY
COMMISSION
PO 00000
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A. Obtaining Information
Please refer to Docket ID NRC–2015–
0172 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2015–0172.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘ADAMS Public Documents’’ and then
select ‘‘Begin Web-based ADAMS
Search.’’ For problems with ADAMS,
please contact the NRC’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The draft
RIS is available in ADAMS under
Accession No. ML15057A346.
• NRC’s PDR: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC–2015–
0172 in your comment submission.
The NRC cautions you not to include
identifying or contact information that
you do not want to be publicly
disclosed in your comment submission.
The NRC will post all comment
submissions at https://
www.regulations.gov as well as enter the
comment submissions into ADAMS.
The NRC does not routinely edit
comment submissions to remove
identifying or contact information.
If you are requesting or aggregating
comments from other persons for
submission to the NRC, then you should
inform those persons not to include
identifying or contact information that
they do not want to be publicly
disclosed in their comment submission.
Your request should state that the NRC
does not routinely edit comment
submissions to remove such information
before making the comment
submissions available to the public or
entering the comment into ADAMS.
II. Background
The NRC is issuing this draft RIS to
clarify the reporting requirements under
part 50.46 of Title 10 of the Code of
Federal Regulations (10 CFR),
‘‘Acceptance Criteria for Emergency
E:\FR\FM\24JYN1.SGM
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Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
Core Cooling Systems for Light-Water
Nuclear Power Reactors.’’ Specifically,
10 CFR 50.46(a)(3) requires licensees to
report to the NRC each change to or
error discovered in an acceptable
emergency core cooling system (ECCS)
evaluation model, or in its application,
and its estimated effect on the limiting
ECCS analysis.
The NRC issues a RIS to communicate
with stakeholders on a broad range of
matters. This may include
communicating and clarifying NRC
technical or policy positions on
regulatory matters that have not been
communicated to or are not broadly
understood by the nuclear industry.
Proposed Action
The NRC is requesting public
comments on the draft RIS. The NRC
staff will make a final determination
regarding issuance of the RIS after it
considers any public comments
received in response to this request.
Dated at Rockville, Maryland, this 14th day
of July 2015.
For the Nuclear Regulatory Commission.
Sheldon D. Stuchell,
Chief, Generic Communications Branch,
Division of Policy and Rulemaking, Office
of Nuclear Reactor Regulation.
[FR Doc. 2015–18113 Filed 7–23–15; 8:45 am]
BILLING CODE 7590–01–P
REAGAN-UDALL FOUNDATION FOR
THE FOOD AND DRUG
ADMINISTRATION
Request for Steering Committee
Nominations
Request for nominations to the
Steering Committee for the Foundation’s
PredicTox project.
ACTION:
The Reagan-Udall Foundation
(RUF) for the Food and Drug
Administration (FDA), which was
created by Title VI of the Food and Drug
Amendments of 2007, is requesting
nominations for its PredicTox Steering
Committee. The Steering Committee
will provide oversight and guidance for
the PredicTox project, and will report to
the Reagan-Udall Foundation for the
FDA’s Board of Directors.
DATES: All nominations must be
submitted to the Reagan-Udall
Foundation for the FDA by August 28,
2015. The PredicTox Steering
Committee members will be selected by
the Reagan-Udall Foundation for the
FDA’s Board of Directors; those selected
will be notified by September 30
regarding the Board’s decision. See the
SUPPLEMENTARY INFORMATION section for
Steering Committee responsibilities,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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19:59 Jul 23, 2015
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selection criteria and nomination
instructions.
ADDRESSES: The Reagan-Udall
Foundation for the FDA is located at
1025 Connecticut Ave. NW., Suite 1000,
Washington, DC 20036.
FOR FURTHER INFORMATION CONTACT:
Questions should be sent to The ReaganUdall Foundation for the FDA, 202–
828–1205, PredicTox@ReaganUdall.org.
SUPPLEMENTARY INFORMATION:
I. Background
The Reagan-Udall Foundation for the
FDA (the Foundation) is an independent
501(c)(3) not-for-profit organization
created by Congress to advance the
mission of FDA to modernize medical,
veterinary, food, food ingredient, and
cosmetic product development;
accelerate innovation; and enhance
product safety. The Foundation acts as
a neutral third party to establish novel,
scientific collaborations. With the
ultimate goal of improving public
health, the Foundation provides a
unique opportunity for different sectors
(FDA, patient groups, academia, other
government entities, and industry) to
work together in a transparent way to
create exciting new research projects to
advance regulatory science.
PredicTox is a public-private
partnership led by the Foundation,
which brings together multiple
stakeholder groups to leverage collective
knowledge, technical expertise, data,
funding, and other resources to explore
systems pharmacology approaches to
better understand and predict adverse
events (AEs). Developing new tools and
approaches for mechanism-based drug
safety assessment and prediction is a
priority for the FDA, as highlighted in
the Agency’s 2011 Strategic Plan for
Advancing Regulatory Science. This
project aims to harness scientific and
technological knowledge, data and
computational capacity across various
sectors and disciplines to develop and
apply systems-based approaches and
multi-scales models to drug safety
assessment in a coordinated manner.
While systems-based approaches can
be applied to the development of
predictive models for any class of drug
or AE, the PredicTox pilot seeks to first
provide a proof of concept pilot by
focusing on large and small molecule
tyrosine kinase inhibitors (TKIs) and
cardiac AEs, specifically left ventricular
dysfunction. TKIs are a rapidly growing
treatment for oncology and select other
therapeutic areas, making them an area
of intense importance for patients, the
FDA, and pharmaceutical
manufacturers. Learnings from the
PredicTox pilot will then be applied to
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44161
other drug classes and/or other
toxicities.
The primary objective of PredicTox is
to advance systems-based science and
tools necessary to support mechanismbased drug safety assessment and
prediction. To accomplish this
objective, the PredicTox pilot project
will be conducted in an iterative,
phased manner over the course of
several years. The first phase will center
on building and populating a knowledge
management platform for molecular
data, preclinical in vivo pharmacologic
and toxicologic data as well as clinical
data from both public and private
sources.
The PredicTox platform will enable
integration, mining, and analysis of
highly heterogeneous data not typically
combined. Future phases of the project
will focus on data mining and
development of analytic and
visualization tools along with
development of multi-scale predictive
models capable of linking events at the
molecular level with events at the
clinical level (AEs) for improved safety
assessment. For additional project
information, see the Reagan-Udall
Foundation Web site.
II. PredicTox Steering Committee Roles
and Responsibilities
The PredicTox Steering Committee
will provide guidance on the operation
of PredicTox, in conjunction with the
RUF Board, project staff, and others.
The Steering Committee will provide
overall programmatic oversight to
ensure a focus on the long-term vision
of the project, while the Scientific
Advisory Committee will provide highly
specialized technical expertise.
The PredicTox Steering Committee
will be charged with several
responsibilities, including:
• Reviewing and approving the
PredicTox Charter
• Monitoring adherence to the
PredicTox mission and operational
principles in the Charter
• Developing metrics and evaluating
the project at various milestones
• Reviewing and approving the
PredicTox Research Agenda
• Reviewing proposals and contracts
submitted to the project
The PredicTox Steering Committee
Chair must be able to complete
additional responsibilities, including:
• Defining the Steering Committee’s
meeting agendas and facilitating those
meetings
• Recommending for termination, as
necessary, any PredicTox Steering
Committee members demonstrating
dereliction of duties as specified in the
PredicTox Charter
E:\FR\FM\24JYN1.SGM
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Agencies
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44160-44161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18113]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2015-0172]
Clarification of Reporting Requirements
AGENCY: Nuclear Regulatory Commission.
ACTION: Draft regulatory issue summary; request for comment.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is seeking public
comment on a draft regulatory issue summary (RIS). This draft RIS
clarifies reporting requirements related to analyses of emergency core
cooling system performance and how these reporting requirements apply
to applicants for and holders of nuclear power reactor operating
licenses, construction permits, combined licenses, standard design
approvals, and manufacturing licenses, and applicants for standard
design certifications.
DATES: Submit comments by September 22, 2015. Comments received after
this date will be considered if it is practical to do so, but the
Commission is able to ensure consideration only for comments received
before this date.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0172. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Mail comments to: Cindy Bladey, Office of Administration,
Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Alexandra Popova, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-001; telephone: 301-415-2876, email: Alexandra.Popova@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2015-0172 when contacting the NRC
about the availability of information for this action. You may obtain
publicly-available information related to this action by any of the
following methods:
Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0172.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The
draft RIS is available in ADAMS under Accession No. ML15057A346.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2015-0172 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Background
The NRC is issuing this draft RIS to clarify the reporting
requirements under part 50.46 of Title 10 of the Code of Federal
Regulations (10 CFR), ``Acceptance Criteria for Emergency
[[Page 44161]]
Core Cooling Systems for Light-Water Nuclear Power Reactors.''
Specifically, 10 CFR 50.46(a)(3) requires licensees to report to the
NRC each change to or error discovered in an acceptable emergency core
cooling system (ECCS) evaluation model, or in its application, and its
estimated effect on the limiting ECCS analysis.
The NRC issues a RIS to communicate with stakeholders on a broad
range of matters. This may include communicating and clarifying NRC
technical or policy positions on regulatory matters that have not been
communicated to or are not broadly understood by the nuclear industry.
Proposed Action
The NRC is requesting public comments on the draft RIS. The NRC
staff will make a final determination regarding issuance of the RIS
after it considers any public comments received in response to this
request.
Dated at Rockville, Maryland, this 14th day of July 2015.
For the Nuclear Regulatory Commission.
Sheldon D. Stuchell,
Chief, Generic Communications Branch, Division of Policy and
Rulemaking, Office of Nuclear Reactor Regulation.
[FR Doc. 2015-18113 Filed 7-23-15; 8:45 am]
BILLING CODE 7590-01-P